Rate , Predictors and Outcome of Chronic Migraine

October 4, 2021 updated by: Mostafa Omar Abdeaziz, Assiut University

Nowadays, headache has been considered as one of the top global disabling medical conditions.1 Migraine is an important type of headache, and one of the chronic multifaceted neuro-inflammatory disorders.2 It is characterized by recurrent throbbing headache pain that typically affects one side of the head, and is often accompanied by nausea and disturbed vision. Migraine headache accounts for 1.4% of all neurological and mental disorders.2 It was reported that the estimated lifetime prevalence of migraine ranged 12%-18%.3 Chronic migraine is defined by the International Classification of Headache Disorders - ICHD-3 as having headaches for ≥ 15 days per month, for ≥ 3 months

, which ≥ 8 days/month are linked to migraine. Chronic migraine affects around 1%-4% of the population and chronic tension-type headache about 2.2%.4 Approximately 25%-50% of those affected also have medication overuse headache, which has a population prevalence of 1%.5 Chronic headache is a severely disabling long-term condition, with higher symptom ,frequency and severity than episodic headache.6

Study Overview

Status

Recruiting

Conditions

Detailed Description

Nowadays, headache has been considered as one of the top global disabling medical conditions.1 Migraine is an important type of headache, and one of the chronic multifaceted neuro-inflammatory disorders.2 It is characterized by recurrent throbbing headache pain that typically affects one side of the head, and is often accompanied by nausea and disturbed vision. Migraine headache accounts for 1.4% of all neurological and mental disorders.2 It was reported that the estimated lifetime prevalence of migraine ranged 12%-18%.3 Chronic migraine is defined by the International Classification of Headache Disorders - ICHD-3 as having headaches for ≥ 15 days per month, for ≥ 3 months

, which ≥ 8 days/month are linked to migraine. Chronic migraine affects around 1%-4% of the population and chronic tension-type headache about 2.2%.4 Approximately 25%-50% of those affected also have medication overuse headache, which has a population prevalence of 1%.5 Chronic headache is a severely disabling long-term condition, with higher symptom ,frequency and severity than episodic headache.6 Diagnostic criteria of chronic migraine according to ICHD(7)

Description:

Headache occurring on 15 or more days/month for more than 3 months, which, on at least 8 days/month, has the features of migraine headache.

Diagnostic criteria:

A. Headache (migraine-like or tension-type-like1) on ≥15 days/month for >3 months, and fulfilling criteria B and C B. Occurring in a patient who has had at least five attacks fulfilling criteria B-D for 1.1 Migraine without aura and/or criteria B and C for 1.2 Migraine with aura

C. On ≥8 days/month for >3 months, fulfilling any of the following:

  1. criteria C and D for 1.1 Migraine without aura
  2. criteria B and C for 1.2 Migraine with aura
  3. elieved by the patient to be migraine at onset and relieved by a triptan or ergot derivative D Not better accounted for by another ICHD-3 diagnosis.

Episodic migraine (EM) is characterized by those with migraine who have 0 to 14 headache days per month, while chronic migraine (CM) is characterized by 15 or more headache days per month.

The relationship between EM and CM is complex. EM progresses to CM at the rate of 2.5% per year [8], and CM often remits to EM (2-year transition rate of 26%) [9].

Several factors have been associated with migraine chronification (predictors) ; such as age:

  • Age *Sex *Presence of depression *Presence of anxiety
  • sleep disorder *obesity *medication compliance *medication overuse
  • coffee * low income *allodynia *other pain disordes comorbidities.

Our aims were to identify factors that predict prognosis in patients with chronic Migraine.

Study Type

Observational

Enrollment (Anticipated)

296

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Assiut, Egypt
        • Recruiting
        • Assiut University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

sample size was calculated using epidemiological information statistical package version 7.

Based on paramaters for cross sectional study;proportion of remitted migraine .26 ,acceptable margin of error 0.05 ,design effect1.95% confidence level.

The required sample size will be 296 migrainous patient .

Description

Inclusion Criteria:

  • 1- both sex 2- all age groups are included 3-history suggestive of chronic migraine 4-accept to participate in the study

Exclusion Criteria:

1-presence of neurological disease other than chronic migraine 2-presence of other chronic medical conditions 3-patients refuse to participate in the study .

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Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess remission rate of chronic migraine to episodic migraine
Time Frame: 2 years
by assessing cases which remit from chronic migraine to episodic migraine according to the criteria of each of them
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
to assess potential predictors of chronic migraine
Time Frame: 2 years
by assessing factors affecting remission of chronic migraine
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2021

Primary Completion (ANTICIPATED)

April 1, 2023

Study Completion (ANTICIPATED)

August 30, 2023

Study Registration Dates

First Submitted

September 28, 2021

First Submitted That Met QC Criteria

October 4, 2021

First Posted (ACTUAL)

October 15, 2021

Study Record Updates

Last Update Posted (ACTUAL)

October 15, 2021

Last Update Submitted That Met QC Criteria

October 4, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • chronic migraine

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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